Abstract 11957: Impact of Post Dilatation on the One-Year Clinical Outcomes of a Large Cohort of Patients Treated Solely With the Absorb Bioresorbable Vascular Scaffold
Background: Although bioresorbable scaffolds (BRS) may have important benefits, their deployment requires more aggressive lesion preparation compared to the best metallic DES due to different radial force and crossing profile. In addition, the benefits of post dilatation (PD) have not been systematically studied, with reports of fracture if the BRS expansion limits are exceeded by excessive PD. We sought to determine the impact of PD on clinical outcomes in a large cohort of patients treated with the Absorb only.
Methods: We evaluated all consecutive patients enrolled in the multicenter, single arm ABSORB EXTEND Study through June 2013. The study allowed treatment of up to 2 coronaries (diameter 2.0 to 3.8mm) and the use of overlapping (lesion length ≤ 28mm). Patients with severe lesion calcification/tortuosity were excluded. Aggressive lesion pre dilatation (balloon to artery ratio of 0.9-1.0) was mandatory and PD was left to the operator’s discretion (if performed, non-compliant balloons up to 0.5mm larger than the Absorb had to be used). Patients were grouped according to whether PD was performed or not, and the one-year incidence of MACE and scaffold thrombosis were compared.
Results: 768 patients were enrolled in the study and PD was performed in 526 (68.4%). There were no significant differences between the PD group and no-PD group in baseline characteristics, moderate calcification (13.7% vs.12.7%, p=0.7) and incidence of B2/C lesions (43.9% vs. 41.8%), as well as lesion length (12.3mm vs. 12.1mm, p=0.6) and RVD (2.6mm for both groups, p=0.2). Residual in-scaffold stenosis (15.4 ± 6.5% with PD, 14.9 ± 6.1 without PD, p=0.3) and the need for bailout scaffold/stent (4.2% with PD, 4.5% without PD, p=0.8) were also comparable. Clinical device success was 99% in both groups. At 1 year, there was no difference in TLF (5.4% in the PD vs. 2.6% in the non-PD group, p=0.13); all individual components of TLR, death, and MI were also similar. There were no significant differences in MACE and def/probable stent thrombosis between the two groups.
Conclusion: These results reflect very similar final angiographic and clinical results achieved with or without post-dilatation in the treatment of low to moderately complex lesions.
Author Disclosures: J. Costa: None. A. Abizaid: None. A. Bartorelli: None. R. van Geuns: None. A. Seth: None. P. Serruys: None.
- © 2014 by American Heart Association, Inc.